Current Challenges And The Way Forwards For Regulatory Databases Of Artificial Intelligence As A Medical Device

Current Challenges And The Way Forwards For Regulatory Databases Of Artificial Intelligence As A Medical Device

Effective regulatory oversight is a key step in ensuring that artificial intelligence as a medical device (AIaMD) is safe in real-world clinical settings. In this Perspective, we provide insights from our experience working with international regulatory databases, informed by our recent research and the expertise of the multidisciplinary authorship team. 

Medigy Insights

Regulatory databases for AI as a medical device face major challenges in data quality, accessibility, and transparency, limiting effective oversight and safe real-world deployment.



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